Cognitive Effects and Potential Mechanisms of TBS in Subjects With MCI

NCT05448768 | Enrolling By Invitation

• 1 other identifier: 202102037A3A0
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to examine the effects and potential mechanisms of theta-burst stimulation (TBS) on cognitive function in individuals with mild cognitive impairment (MCI).

Conditions

Mild Cognitive Impairment

Keywords

Mild Cognitive Impairment; theta-burst stimulation; repetitive transcranial magnetic stimulation (rTMS)

Outcome Measures

Primary Outcomes (2)

• Mini-Mental State Examination ( MMSE )

  Change from baseline Mini-Mental State Examination total scores immediately after TBS intervention

  Baseline and immediately after 2 weeks of TBS and 8-week follow-up after TBS

• Montreal Cognitive Assessment

  Change from baseline Montreal Cognitive Assessment total scores immediately after TBS intervention

  Baseline and immediately after 2 weeks of TBS and 8-week follow-up after TBS

Secondary Outcomes (1)

• The standard uptake values changes of FDG-PET

  Before and immediately after TBS intervention

Study Arms (2)

Amyloid-positive MCI

ACTIVE COMPARATOR

The subjects will receive active stimulation of standard intermittent TBS (iTBS) protocol.

Device: TBS for Amyloid-positive MCI

Amyloid-negative MCI

ACTIVE COMPARATOR

The subjects will receive active stimulation of standard intermittent TBS (iTBS) protocol.

Device: TBS for Amyloid-negative MCI

Interventions

TBS for Amyloid-positive MCI DEVICE

The investigators will perform standard intermittent TBS (iTBS) parameters to left DLPFC of every patient in the study. The frequency parameters of TBS are 3-pulse 50-Hz bursts, every 200 ms at 5 Hz, and the intensity is 90% of active motor threshold. A single session of iTBS contains 2 s of TBS repeated every 10 s for 20 times. In this study, The investigators will give two sessions of iTBS separated by 15 min.

Amyloid-positive MCI

TBS for Amyloid-negative MCI DEVICE

The investigators will perform standard intermittent TBS (iTBS) parameters to left DLPFC of every patient in the study. The frequency parameters of TBS are 3-pulse 50-Hz bursts, every 200 ms at 5 Hz, and the intensity is 90% of active motor threshold. A single session of iTBS contains 2 s of TBS repeated every 10 s for 20 times. In this study, The investigators will give two sessions of iTBS separated by 15 min.

Amyloid-negative MCI

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects aged 50-90 year
• Subjects meet Petersen's criteria for mild cognitive impairment (Petersen, Smith et al. 1999)
• The CDR of MCI patients can be 0-0.5
• Amyloid PET should ever be performed

You may not qualify if:

• Any subject has a definite diagnosis of epilepsy or history of seizure attack.
• Current or past history of clinically significant neurological insults affecting brain structure or function like completed stroke, head injury or brain tumor.
• Any subject has clinically significant or unstable medical diseases including metabolic, renal,liver, lung or cardiovascular disorders including metabolic, renal, liver, lung or cardiovascular disorders.
• Any subject has current alcohol or other substances abuse and/ or dependence within the recent one year, or prolonged history of major psychiatric disorder like schizophrenia,bipolar disorder, and previously prolonged substances abuse.
• Any females who is pregnant or lactating.
• Withdrawal criteria
• Complications onset after intervention that affect efficacy and safety judgments.
• New onset or progression of disease that may affect outcomes.
• Use of other therapies or drugs during the intervention period to change cognitive functions.
• Any subjects who are recognized as high risk of adverse effects by principle investigator.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, Taiwan

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• KUAN YI WU

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The investigators will perform standard intermittent TBS (iTBS) parameters to left DLPFC of every patient in the study. The frequency parameters of TBS are 3-pulse 50-Hz bursts, every 200 ms at 5 Hz, and the intensity is 90% of active motor threshold. A single session of iTBS contains 2 s of TBS repeated every 10 s for 20 times. In this study, we will give two sessions of iTBS separated by 15 min.

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: July 7, 2022
• Study Start: September 13, 2022
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)